Patient interface with adjustable cushion

ABSTRACT

A patient interface of the present invention includes a faceplate including a plurality of headgear attachment elements, a seal member operatively coupled to the faceplate; and an adjustment mechanism coupling the seal member to the faceplate. The adjustment mechanism controls the position of the seal member relative to the faceplate such that the seal member is moveable from a first position to a second position and is maintained in the second position during use of the patient interface after being moved to the second position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119(e) fromprovisional U.S. patent application No. 60/708,319 filed Aug. 15, 2005,the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to a patient interface for use in anon-invasive pressure support or ventilation system that supplies a flowof gas to the airway of a patient, and, in particular, to a patientinterface having a seal member that is selectively adjustable relativeto a faceplate or other seal supporting structure so that the user cancontrol the position of the seal to optimize comfort and fit while alsominimizing gas leak.

2. Description of the Related Art

There are numerous situations where it is necessary or desirable todeliver a flow of gas non-invasively to the airway of a patient, i.e.,without intubating the patient or surgically inserting a tracheal tubein the esophagus. For example, it is known to ventilate a patient usinga technique known as non-invasive ventilation (NIV). It is also known todeliver a pressure support therapy to treat a medical disorder, such assleep apnea syndrome, in particular, obstructive sleep apnea (OSA),cheynes-stokes respiration, and congestive heart failure. Typicalpressure support therapies include providing a continuous positiveairway pressure (CPAP) or a variable airway pressure to the airway ofthe patient. Examples of variable airway pressure therapies includeproviding a bi-level pressure that varies with the patient's respiratorycycle, a proportional pressure that varies the delivered pressure basedon the patient's respiratory effort or flow, and an auto-titratingpressure that varies the delivered pressure based on the monitoredcondition of the patient.

Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface, which is typically a nasal ornasal/oral mask, on the face of a patient to interface the ventilator orpressure support system with the airway of the patient so that a flow ofgas can be delivered from the pressure/flow generating device to theairway of the patient. Typically patient interfaces include a mask shellhaving a cushion attached to the shell that contacts the surface of thepatient. The mask shell and cushion are held in place by a headgear thatwraps around the head of the patient. The mask and headgear form thepatient interface assembly. A typical headgear includes flexible,adjustable straps that extend from the mask to attach the mask to thepatient.

Because such masks are typically worn for an extended period of time, avariety of concerns must be taken into consideration. For example, inproviding CPAP to treat OSA, the patient normally wears the patientinterface all night long while he or she sleeps. One concern in such asituation is that the patient interface is as comfortable as possible,otherwise the patient may avoid wearing the interface device, defeatingthe purpose of the prescribed pressure support therapy. It is alsoimportant that the interface device provides a tight enough seal againsta patient's face without discomfort so that gas leakage from the systemat the patient-seal interface is minimized. A dilemma arises in that inorder for the mask to maintain a seal without any undue gas leaks aroundthe periphery of the mask, the mask may be compressed against thepatient's face, which may decrease comfort.

Many patient interfaces have been developed that attempt to balance thecompeting interests of patient comfort versus minimizing leakage. Inaddressing this issue, many patient interfaces have focused on thedesign of the cushion. Early cushion designs were typically a flap ofmaterial or a balloon, i.e., air-filled cushion, that contacted the faceof the user. Further design developments including contouring thepatient contacting portion of the cushion and/or making the sealcustomizable to the surface or underlying tissues of the user. Stillfurther cushions have employed multiple flaps so that the outermost flapprovides a sealing function. See, e.g., U.S. Pat. No. 4,971,051 toToffolon.

In addition, U.S. Pat. No. 6,530,373 (“the '373 patent”) discloses apatient interface in which the position of the seal relative to theconduit is adjustable over discrete positions. This is done in the '373patent because there is little or no control of the position of theconduit relative to the patient's face. Allowing the seal position to beadjusted allows the seal to set to a proper angle on the user dependingon the position of the conduit. This patient interface, however, doesnot provide a stable platform on which the seal is mounted.

Although these conventional patient interfaces have advanced the art,the need still exists for a patient interface that improves uponexisting devices, for example, to maximize patient comfort whileminimizing leak, during delivery of a positive airway pressure or flowof gas to the airway of the user. In addition, existing patientinterfaces also may not provide a stable platform that supports thecushion on the patient's face.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide apatient interface that overcomes the shortcomings of conventionalpatient interfaces. This object is achieved according to one embodimentof the present invention by providing a patient interface that includesa faceplate that includes a plurality of headgear attachment elements, aseal member operatively coupled to the faceplate, and an adjustmentmechanism that couples the seal member to the faceplate. The seal memberis adjustable relative to the faceplate from a first position to asecond position and is maintained in the second position by theadjustment mechanism during use of the patient interface. The adjustmentmechanism provides either a plurality of discrete positions for the sealmember relative to the faceplate or a potentially infinite number ofadjustment positions between these components.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a first embodiment of a patientinterface according to the principles of the present invention shownschematically connected to a pressure support system;

FIG. 2 is a rear perspective view of the patient interface of FIG. 1;

FIG. 3 is a sectional view of the adjustment mechanism in the patientinterface of FIG. 1;

FIG. 4 is a sectional view of the seal member and faceplate couplingconfiguration in the patient interface of FIG. 1;

FIG. 5 is an exploded view of the patient interface of FIG. 1;

FIG. 6 is an exploded view of the adjustment mechanism in the patientinterface of FIG. 1;

FIG. 7 is a front perspective view of a second embodiment of a patientinterface according to the principles of the present invention shownschematically connected to a pressure support system;

FIG. 8 is a rear perspective view of the patient interface of FIG. 7;

FIG. 9 is a side sectional view of the patient interface of FIG. 7;

FIG. 10 is an exploded view of the patient interface of FIG. 7;

FIG. 11 is an exploded view of the adjustment mechanism in the patientinterface of FIG. 7;

FIG. 12 is a front perspective view of a third embodiment of a patientinterface according to the principles of the present invention;

FIG. 13 is a rear perspective view of the patient interface of FIG. 12;

FIG. 14 is an exploded view of the patient interface of FIG. 12;

FIG. 15 is a side view of a fourth embodiment of a patient interfaceaccording to the principles of the present invention;

FIGS. 16A and 16B are side views showing the adjustment of the sealmember relative to the faceplate in the patient interface of FIG. 15;

FIG. 17 is a side view of the seal member in the patient interface ofFIG. 15;

FIGS. 18-20 are side views of alternative embodiments of an adjustmentmechanism that controls the position of the seal member relative to thefaceplate;

FIG. 21 is a side view of a fifth embodiment of a patient interfaceaccording to the principles of the present invention;

FIG. 22 is a side view of a sixth embodiment of a patient interfaceaccording to the principles of the present invention;

FIG. 23 is a side view of a seventh embodiment of a patient interfaceaccording to the principles of the present invention;

FIGS. 24A-24C are side views illustrating the adjustment of the sealmember relative to the faceplate in the patient interface of FIG. 23;

FIG. 25 is a side, partial sectional, view of an eighth embodiment of apatient interface according to the principles of the present invention;

FIG. 26 is a perspective view of alternative configurations for the sealmember mount in the patient interface of FIG. 23;

FIG. 27 is an exploded view of a ninth embodiment of an adjustmentmechanism according to the principles of the present invention;

FIG. 28 is a side sectional view of a patient interface including theadjustment mechanism of FIG. 27;

FIG. 29 is an exploded view of a tenth embodiment of an adjustmentmechanism according to the principles of the present invention;

FIG. 30 is a front perspective view of an eleventh embodiment of apatient interface according to the principles of the present invention;

FIG. 31 is an exploded view of a twelfth embodiment of a patientinterface according to the principles of the present invention;

FIG. 32 is an exploded view of a thirteenth embodiment of a patientinterface according to the principles of the present invention;

FIG. 33 is a side view, partially in section, of a fourteenth embodimentof a patient interface according to the principles of the presentinvention;

FIG. 34 is a side sectional view of a portion of a patient interfaceaccording to a fifteenth embodiment of the present invention;

FIG. 35 is a side view of a sixteenth embodiment of a patient interfaceaccording to the principles of the present invention;

FIG. 36 is a front view of the patient interface of FIG. 35 including adetailed view of an adjustment mechanism used therein;

FIG. 37 is front view of a seventeenth embodiment of a patient interfaceaccording to the principles of the present invention; and

FIG. 38 is a side view the patient interface of FIG. 37 including adetailed view of an adjustment mechanism used therein.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

FIGS. 1-6 illustrate a first embodiment of a patient interface 30according to the principles of the present invention. Patient interface30 is shown schematically connected to a pressure/flow generating system32 via a patient circuit 34, which communicates gas from the pressuresupport system to the patient interface. Pressure/flow generating system32 is any conventional ventilator or pressure support system. Patientcircuit 34 is typically a flexible hose or tube that communicates anoutput of the pressure/flow generating system with the patientinterface. It is to be understood that other accessories used inpressure/flow generating systems, such as a humidifier, pressure sensor,flow sensor, temperature sensor, humidity sensor, bacteria filter, etc.can be used in conjunction with the patient interface of the presentinvention.

Examples of pressure support systems include, but are not limited to: aventilator, continuous positive airway pressure (CPAP) device, or avariable pressure device, e.g. an auto-titrating device, proportionalassist ventilation (PAV®) device, proportional positive airway pressure(PPAP®) device, C-Flex™ device, Bi-Flex device, or a BiPAP® devicemanufactured and distributed by Respironics, Inc. of Pittsburgh, Pa., inwhich the pressure provided to the patient varies with the patient'srespiratory cycle so that a higher pressure is delivered duringinspiration than during expiration, or other pressure support device.Auto-titrating devices vary the pressure delivered to the patient basedon the monitored condition of the patient. C-Flex and Bi-Flex devicesvary the pressure based on the flow in the pressure support system or atthe airway of the patient, and a PAV device varies the pressure based onthe patient's respiratory effort. It is to be understood that thepresent invention contemplates using any pressure support system withthe patient interface of the present invention.

Patient interface 30 includes a faceplate 36 and a seal member 38, whichis also referred to as a cushion or seal, coupled to the faceplate. Inan exemplary embodiment of the present invention, faceplate 36 is asubstantially rigid member that serves as a stable platform on which theseal member is mounted. The present invention also contemplates that thefaceplate can be flexible, or have flexible portions to maximize the fitand comfort of the patient interface device on the user. The stabilityof the faceplate as a support structure for the seal member isaccomplished due to the fact that the faceplate itself is secured to theuser by means of a headgear assembly (not shown) coupled directly to thefaceplate. It can be appreciated that any suitable headgear assembly canbe used to secure the patient interface on the user, and that theheadgear straps can be attached to the patient interface in any suitablefashion. The details of one technique for attaching the headgear strapsto the faceplate are discussed below with reference to FIGS. 7-14.

Referring again to FIGS. 1-6, faceplate 36 includes a seal supportportion, generally indicated at 40, to which seal member 38 is mounted.An orifice 42 is provided in seal support portion 40 of faceplate 36 toenable a flow of gas from patient circuit 34 to be communicated to achamber 44 defined by the seal member of the patient interface. Gas isalso communicated in the opposite direction, i.e., from the interior ofthe patient interface to the patient circuit, through orifice 42. Theflow of gas between the seal member and the patient circuit isillustrated by arrow A in FIG. 4.

A coupling member 46, which in the illustrated embodiment is an elbowpiece, connects the patient circuit to the interface device via orifice42. Of course, the present invention also contemplates eliminatingcoupling member 46 and coupling the patient circuit directly to thefaceplate. Coupling member 46 includes a pair of prongs 48 that define achannel 50 to receive the wall of the faceplate and the end of sealmember 38. In an exemplary embodiment, the end of seal member 38 isjoined to a ring 52 that is more rigid than the end of the seal memberto provide a strong, stable mechanical coupling of the seal member tothe faceplate. It is to be understood that ring 52 can be eliminated.This configuration allows coupling member 46 to rotate relative tofaceplate 36, as indicated by arrow B in FIG. 1. It is to be furtherunderstood that other techniques for securing the coupling member to thefaceplate are contemplated by the present invention.

Faceplate 36 includes lateral portions 54 and a forehead support,generally indicated at 56. The forehead support includes a forehead arm58, a forehead pad support 60, and a forehead pad 62. Lateral portions54 are disposed over the user's cheeks when the patient interface isdonned by the user and forehead support extends along the bridge of thenose up to the user's forehead. The entire faceplate can be formed as aunitary structure, or may be formed as separate elements that areconnected together in either a fixed relation or in an adjustablerelation. For example, the present invention contemplates that theforehead arm can be coupled to the lateral portions such that theforehead arm is rotatable relative to the lateral portions. Lateralportions 54 and forehead pad support 60 include headgear attachmentelements to which a headgear strap is attached. In the illustratedembodiment, the headgear attachment members are in the form of a slot 64defined in the various portions of the faceplate. These slots receivethe straps of the headgear as known in the art. As noted above, theheadgear attachment elements can have any conventional configuration forattaching a headgear strap to the faceplate.

In the illustrated exemplary embodiment of forehead support 56, foreheadpad support 60 is coupled to forehead arm 58, and, in particular, isintegral therewith. The present invention also contemplates adjustablycoupling the forehead arm to the remainder of the faceplate, such as theportion including lateral portions 54, so that the position of theforehead pad support relative to the lateral portions of the faceplatecan be adjusted enabling the patient interface to fit a wide variety ofdifferently sized faces. An example of an forehead support assembly thatallows adjustment of the forehead arm and/or the forehead support pad isdisclosed in U.S. Pat. No. 7,069,932 (“the '932 patent”) the contents ofwhich are incorporated herein by reference.

The present invention also contemplates that the forehead pad support beseparable from the forehead arm and/or that the forehead pad support canbe attached to the forehead arm such that the forehead pad support ismoveable relative to the forehead arm. These techniques for attachingforehead pad support to the forehead arm are also taught in the '932patent.

Forehead pad 62 is made from any material, such as gel, foam, silicone,or any combination thereof, suitable for contacting the surface of theuser. In addition, the forehead pad is attached to the forehead padsupport in any conventional manner, and may be permanently attached toor separable from the forehead pad support. While a single forehead padis shown in the figures, the present invention contemplates thatmultiple pads may be provided. Moreover, each for forehead pad can haveany desired configuration. As example of a configuration that allows theforehead pad to “self-align” on the user and that is suitable for use inthe present invention is disclosed in U.S. patent application Ser. No.10/884,060 (publication no. US-2005-0011522-A1) the contents of whichare incorporated herein by reference.

Because the patient interface of the present invention is intended foruse in a non-invasive ventilation-type of ventilation/pressure supportsystem, an exhaust assembly 66 is provided along the gas flow path toallow the patient's exhaled gasses to vent to atmosphere. In the presentembodiment, exhaust assembly 66 is provided in a coupling member 46. Thepresent invention also contemplates proving the exhaust assembly in thepatient interface, such as in the seal member of the patient interface,the faceplate, or at a plurality of such locations. Placing the exhaustassembly close the patient interface minimizes the deadspace in thebreathing circuit.

The present invention contemplates that exhaust assembly 66 can have anyconfiguration, so long as the function of exhausting a sufficient amountof gas to atmosphere is achieved. For example, the exhaust assembly canbe configured to provide a continuous flow rate for the venting ofexhaust gas to atmosphere, or can be configured to provide a variableflow rate; dependent, for example, on the pressure of the gas in theclosed system. In the illustrated embodiment, exhaust assembly 66 isdefined by a plurality of vent holes 68 provided in the wall of couplingmember 46. The number, size, hole pattern, and shape of the holes canhave any configuration. One example of a multiple-hole type of exhaustassembly suitable for use in the present invention is disclosed in U.S.Pat. No. 6,851,425, the contents of which are incorporated herein byreference. It should again be emphasized that any suitable exhaustconfiguration, located at any suitable position, on or near the patientinterface can be used with the patient interface of the presentinvention.

Patient interface 30 includes an adjustment mechanism 70 that allows theposition of seal member 38 relative to faceplate 36 to be adjusted froma first position to a second position. Adjustment mechanism 70 alsomaintains the seal member in the second position during use of thepatient interface. In the illustrated exemplary embodiment, the useractuates the adjustment mechanism by rotating a knob portion 72, asindicated by arrow C in FIG. 3. As discussed in detail below, thiscauses an upper portion of seal member 38 to be pushed away from orpulled toward faceplate 36, as indicated by arrow D. Because the sealmember is relatively flexible, this pushing or pulling changes thecontact of the seal member of the surface of the user, thereby allowingthe user to adjust the seal member to fit their particular facialstructure or comfort needs. This can be done while the patient interfaceis donned on the user.

An exemplary embodiment of adjustment mechanism 70 according to oneembodiment of the present invention is shown, in detail, in FIGS. 3 and6. Adjustment mechanism 70 is coupled to faceplate 36 and seal member 38and includes knob portion 72, barrel member 74, and stem 76. In theillustrated embodiment, a cap 78 is attached to knob portion 72. Ofcourse, the cap and knob portion can be formed from a single piece. Manyof the components of the adjustment mechanism are disposed in a recess80 provided in faceplate 36 so a manually actuatable portion 82 isexposed at the front of the mask and a seal member contacting portion 84is disposed on the opposite side of the faceplate and engages the sealmember.

Knob portion 72 is secured within recess 80 so that it is free to rotatewithin the recess but does not pull out from the recess. In an exemplaryembodiment, a pair of tabs 86 are provided in an outer surface of theknob portion. These tabs insert into a channel defined on an inner wallof the recess so that once the tabs are engaged in the channel, the knobportion is rotatably secured to the faceplate. Rotating knob portion 72causes barrel member 74 to also rotate due to threads 88 provided on aninterior surface of the knob portion engaging a corresponding threads 90provided on an exterior surface of the barrel member. Barrel member 74does not move relative to the faceplate when it is rotated. A tab or lip92 is provided on the end of the barrel member that engages threads 94provided on stem 76. Thus, as the barrel member rotates in a fixedposition, the lip engaging the threads of the stem cause the stem tomove, as indicated by arrow D. An optional alignment member 96 providedon knob portion 72 inserts into a channel 98 defined in stem 76 to keepthe stem properly aligned as it moves inward and outward relative to thefaceplate.

Adjustment mechanism 70 is coupled to seal member 38 such that theadjustment mechanism moves at least an upper portion of the seal memberrelative to the faceplate—the upper portion of the seal member being theportion that is disposed over the bridge of the user's nose when thepatient interface is worn by the user. In the illustrated exemplaryembodiment, a ball-and-socket connection is used to couple theadjustment mechanism to the seal member. More specifically, a ball 100is provided on the end of stem 76 and a socket 102 is provided on sealmember 38. Of course, the present invention contemplates that thelocation of the ball-and-socket can be reversed.

The use of this type of connection provides a high degree of freedom ofmovement for the seal member so that the whole seal member does notsimply move linearly with respect to the faceplate when the adjustmentmechanism is actuated. Instead, this configuration allows the upperportion to move on one direction, e.g., to be pushed away from thefaceplate, while the lower portion at the opposite end of the sealmember is moved in an opposite direction, e.g., is pushed toward thefaceplate. In essence, the seal member is capable of being pivoted,articulated, or otherwise moved relative to the faceplate by this typeof connection between the adjustment mechanism and the seal member. Thisconnection also allows the seal member to move side-to-side so that theseal member is properly seated on the user. It is to be understood thatthe present invention contemplates using other connecting techniques tojoin the attachment mechanism with the seal member, including providinga rigid connection of the adjustment mechanism to the seal member sothat the seal member does more linearly with respect to the faceplate.

A generally rigid annular ring 104 is disposed around the perimeter ofseal member 38 to provide a secure attachment point for the adjustmentmechanism to the seal member. The present invention contemplatesattaching ring 104 to the seal member using any conventional technique,such as adhering, mechanically coupling, or two-shot molding the ring tothe seal member. Grooves may be provided in the seal member in which thering is seated. In addition, the ring need not extend around the entireperimeter of the seal member. The present invention also contemplatesthat the annular ring can make out of the same material of the sealingmember, but with thicker section.

In the illustrated exemplary embodiment, seal member 38 includes atleast one pleat 106 (which can also be referred to as a fold or gusset)provided at a portion of the seal member so that the seal member has thedesired degree of flexibility. In this case, pleats 106 are provided atand upper portion of the seal member so that this portion of the sealmember can expand and contract with adjustment of the adjustmentmechanism. Pleats 106 are oriented such that the pleat protrudes intochamber 44 with a channel 108 defined on the exterior surface of theseal member. Of course, the present invention contemplates orienting thepleats in the opposite direction or eliminating them entirely. Inaddition, the number, size, configuration, and location of the pleats onthe seal member can also be varied so that the seal member flexes wheredesired.

A pleat 110 is also provided at or near a patient contacting portion 112of the seal member to control the collapsibility of the patientcontacting portion of the seal. An example of such a pleat is disclosedin U.S. patent application Ser. No. 11/312,026(publication no.US-2006-0130844-A1), the contents of which are incorporated herein byreference.

A flap 114 is provided at patient contacting portion 112 of the sealmember to provide a good seal between the seal member and the surface ofthe user. Flap 114 extends around a perimeter of the seal member. Ofcourse, the present invention also contemplates providing flap 114 onlyat selected locations along the perimeter of the seal. In addition, thepresent invention contemplates providing multiple flaps at the patientcontacting portion.

Seal member 38 can be made from any suitable material, such as gel, anair filled bladder, silicone, foam, rubber, or combination of materials,as is known to those skilled in the art. Thus, a complete listing of allpossible materials or combinations of materials suitable for use in theseal member is omitted from the present application for purposes ofbrevity. Seal member 38 can also have any one of a variety ofconfigurations. For example, the seal member can be a nasal seal thatseals only over the user's nose or a nasal/oral seal that seals over thenose and mouth. Again, the art is replete with different sealconfigurations. To the extent that any of these different configurationscan be used in the patient interface of the present invention, thepresent invention contemplates doing so.

FIGS. 7-11 illustrate a second, albeit similar, embodiment of a patientinterface 130 according to the principles of the present invention.Patient interface 130 includes a faceplate 136 and a seal member orcushion 138, which is coupled to the faceplate such that a chamber 144define by the seal member communicates with patient circuit 34 via anorifice 142 defined in the faceplate. As in the previous embodiment,coupling member 46 is rotatably coupled to the faceplate so that gas canflow to and from the airway of the user through the patient interface.Seal member 138 is coupled to the faceplate by means of a ring 152 towhich the seal member is secured. The seal member is either fixed to thefaceplate or is rotatable relative thereto. The present invention alsocontemplated that ring 152 can be eliminated and the seal member can beattached to the faceplate (rotatable or fixed) using any conventionaltechnique.

Faceplate 136 includes a body portion 154 to which is coupled the sealmember, and a forehead arm 158 that supports a forehead support 156.Forehead support includes a forehead pad support 160 and a forehead pad162 coupled thereto. In this embodiment, the forehead pad is a flexiblecushion that slips over the forehead pad support. A pair of slots 164are provided on the forehead pad support to function as the headgearattachment members. It should be expressly understood that thealternative embodiments for the various features of the patientinterface, including the faceplate, seal member, forehead arm, foreheadsupport, forehead pad support, forehead pad, and headgear attachmentmembers discussed above are equally applicable to this embodiment, aswell as the other embodiments discussed herein.

One difference between patient interface 130 and patient interface 30 onthe previous embodiment, is the configuration for headgear attachmentmembers 166 provided on body portion 154 of faceplate 136. In thisembodiment, headgear attachment members 166 are sockets for receivingball clips (see headgear clips 265 in FIGS. 12-14) that are attached tothe headgear straps. Examples of various configurations for aball-and-socket type of headgear attachment is disclosed in U.S. patentapplication Ser. No. 10/629,366 (publication no. US-2004-0025883-A1)thecontents of which are incorporated herein by reference.

Another difference between patient interface 130 and patient interface30 on the previous embodiment resides in the configuration for anadjustment mechanism 170 that controls the position of seal member 138relative to faceplate 136. Adjustment mechanism 170 provides the samefunction, i.e., moves the upper portion of the seal member relative tothe faceplate, as that of the previous embodiment, but has a differentconfiguration for doing so. Adjustment mechanism 170, which is perhapsbest shown in FIGS. 9-11, includes a knob portion 172, a ratchet member173, a barrel member 174, and a stem 176 and is coupled to faceplate 136via a protrusion 180, where a channel is defined in the faceplate tohouse the components of the adjustment mechanism. A lock ring 178secures barrel member 174 to the faceplate by engaging both thefaceplate and a channel 184 defined in the barrel member.

Knob portion 172 is attached to ratchet member 173 using anyconventional technique, such as by a friction engagement. Ratchetmechanism 173 include prongs 184 that engage teeth 186 provided onbarrel member 174 so that rotating the knob portion and the ratchetmember also rotates the barrel member. The barrel member includesthreads 188 on an interior surface that engage threads 190 provided onan exterior surface of stem 176. As a result, rotating barrel member 174causes stem 176 to move relative to the faceplate, as indicated by arrowD in FIG. 9, within the interior of the barrel member, which does notmove. As in the embodiment of FIGS. 1-6, the end of the stem is coupledto seal member 138 via a ball 192 provided at the end of the stem and asocket 102 provided on a ring 104 that is coupled to the seal memberusing any conventional technique. The ratchet mechanism of thisembodiments prevent over-tightening of the adjustment mechanism ineither direction (inward or outward) because on the end of travel isreached, prongs 184 begin to flex away from teeth 186 so that they slipover teeth and prevent the ratchet member from rotating the barrelmember.

In the embodiments for the patient interface discussed above withrespect to FIGS. 1-11, the seal member is relatively free-floating withrespect to the faceplate. In other words, control of the position of thepatient contacting portion seal member relative to the faceplate isprovided by the attachment mechanism. The seal member is relatively freeto move side-to-side, i.e., along a horizontal axis, but movement alonga vertical axis is controlled by the attachment mechanism. Of course,the seal member is also connected to the faceplate at orifice 42 or 142,but this connection does not control the position of the patientcontacting portion of the seal member. It merely serves to couple theseal member to the faceplate. The present invention, however,contemplates providing other attachment points between the seal memberand the faceplate to control the position of the patient contactingportion of the seal member so that the user can adjust or control thecontact of the seal on his or her face to optimize comfort and sealingability.

FIGS. 12-14 illustrate an example of a third embodiment for a patientinterface 200 that includes multiple contact points between faceplate202 and a seal member 204 to provide greater control over the positionof the patient contacting portion of the seal member relative to thefaceplate than in the previous embodiments. In this embodiment, sealmember 204 comprises a cushion 206, a flap 208, and a seal mount member210. In this particular embodiment, flap 208 includes an attachment ring212 that snaps onto an outer edge portion 214 of the seal mount membercapturing the cushion between the seal mount member and the flap. In theassembled configuration, the seal member.

The seal member is coupled to the faceplate by engaging the seal mountmember with the faceplate at three attachment points. Two of theattachment points are at the lower left and right sides of the sealmount member, and the third is the attachment between the seal mountmember and the faceplate provided by adjustment mechanism 216. Morespecifically, a pair of pivot members 218 (only one of which isillustrated) are provided on each side of faceplate 202, and acorresponding pair of pivot member couplings 220 are provided on sealmount member 210 (only one of which is illustrated). When assembled, thepivot members rotate within the pivot member couplings to allowtwo-dimensional movement, i.e., rotation about an axis defined betweenthe pivot members, of the seal member relative to the faceplate underthe control of the adjustment mechanism. There is little or noside-to-side movement of the seal member relative to the faceplate.

In this embodiment, adjustment mechanism 216 includes a knob portion 222and a stem 224. The knob portion and a protruding portion 226 offaceplate 202 are coupled such that the knob portion rotates withinrelative to the faceplate but remains coupled thereto. The knob portionincludes internal threads that engage the external threads on the stemso that rotating the knob portion causes the stem to move axially withinthe knob portion. An end portion 228 of the step is rotatably coupled toa mounting member 230 provided on seal mount member 210. Of course, aball-and-socket coupling between the step and the seal mount member isalso contemplated by the present invention, as are other couplingtechniques, including fixed couplings.

Seal member 204 also includes a sealing gasket 232 that couples the sealmember to coupling member 46. Sealing gasket 232 includes a flexibleneck portion 234 that couples to a coupling portion 235 of the couplingmember. The neck portion is flexible to allow the seal member to moverelative to the faceplate. A lock ring 236 and a washer 238 are providedto couple the sealing gasket to the coupling member. It is to beunderstood that the present invention contemplates using anyconventional technique to couple the seal member to the patient circuitand/or coupling member 46. In an exemplary embodiment, the couplingbetween the seal member to the patient circuit and/or coupling member isa rotatable coupling so that the position of the patient circuitrelative to the patient interface can be changed.

Another feature of patient interface 200 is that knob portion 222 andcoupling member 46 are configured such that the coupling member can beselectively secured to the knob portion. The allows the patient circuitto be maintained in an over-the-head relationship on the user, which isdesirable to some. When not attached to knob portion 222, the couplingmember and patient circuit can move freely, e.g., rotate relative to thefaceplate, which is also desirable to some patients so that they canposition the breathing circuit at a location that best suits them. In anexemplary embodiment, coupling member 46 includes a protrusion 240 andknob portion 222 includes a recess 242 adapted to receive the protrusionwhen the coupling member is dispose over the knob portion. Thus, theengagement of the protrusion in the recess secures the coupling memberto the faceplate. Of course, the location of the protrusion and recesscan be reversed. In addition, other techniques for coupling (permanentlyor selectively) the coupling member and/or patient circuit to thefaceplate are contemplated by the present invention.

As in the previous embodiments, patient interface 200 includes aforehead support 256 that is supported by a forehead arm 258. In theillustrated exemplary embodiment, forehead support 256 includes aforehead pad support 260 that is rotatably connected to the foreheadarm. A forehead pad 262 is coupled to the forehead pad support. In thisembodiment, the forehead pad is a silicone pad that is selectivelyattached to the forehead pad support. Of course, other configurations,materials, sizes, etc. for the forehead pad are contemplated by thepresent invention, as are other configurations, materials, sizes, etc.for the forehead pad support and forehead arm.

A headgear assembly (not shown) attaches the patient interface on thehead of the user. The headgear assembly includes straps that attach tothe patient interface via headgear slots 264 provided in forehead padsupport and via headgear clips 265. Headgear clips 265 attach toheadgear attachment members 266 provided on faceplate 202 via aball-and-socket configuration and include slots 268 into which theheadgear straps are inserted.

FIGS. 15-17 illustrate a fourth embodiment of a patient interface 300according to the principles of the present invention. Patient interface300 includes a faceplate 302 and a seal member 304 coupled to thefaceplate. The seal member includes a cushion 306, a collar 308, and aseal mount member 310 to which the cushion and collar are mounted orotherwise attached. The seal mount member is coupled to the faceplatevia and adjustment mechanism 316. The seal member is also coupled to thefaceplate via collar 308, which communicates the interior of the sealmember with coupling member 46.

As best illustrated in FIG. 17, collar 308 includes a first end portion311 that attaches to faceplate 302, coupling member 46, the patientcircuit, or any combination thereof. A second end portion 312 attachesto seal mount member 310. Collar 308 is formed from a flexible ormaterial or is structured so as to be flexible so that the position ofthe seal member can be adjusted relative to the faceplate while allowinggas to communicate between the patient circuit and the interior of theseal member. In the illustrated embodiment, the flexibility of the sealis enhanced by a plurality of pleats 313 defined in the wall of thecollar between the first and second end portions. Of course, othersizes, configurations, and locations for the pleats are contemplated bythe present invention.

Seal member 304 also includes a retaining member 314 coupled to the wallof collar 308. Retaining member 314 provides structural support for thecollar to help keep the seal member properly positioned in the user. Inan exemplary embodiment of the present invention, retaining member 314is a flexible metallic band that is attached to the lower portion of thecollar. A pair of attachment members 315 are provided for attaching theband on the collar. It is to be understood that the present inventioncontemplates that the size, shape, degree of flexibility, location,number, and material of the retaining member can be varied depending thesupport needs for the collar.

As noted above, in this embodiment and in the previous embodiments,adjustment mechanism 316 control the position of the seal memberrelative to the faceplate. This is demonstrated in FIGS. 16A and 16B,where FIG. 16A shows the upper portion of the seal member moved close tothe faceplate (the full inward position) and FIG. 16B shows the upperportion of the seal member moved away from the faceplate (the filloutward position). It should be noted that when the adjustment mechanismis in the inward position, a first plane 318 generally defined by theseal member, intersects a second plane 320 generally defined by thefaceplate, at a location somewhere above the adjustment mechanism. Inaddition, the bottom portion of the seal member moves away from theframe, as indicated by arrow E. On the other hand, when the adjustmentmechanism is in the outward position, first plane 318 intersects asecond plane 320 at a location somewhere below the adjustment mechanism,and the bottom portion of the seal member moves toward the frame, asindicated by arrow F.

While FIGS. 16A and 16B show the bottom of the seal member as moving,the present invention also contemplates that the seal member can beconfigured and arranged such that a portion of the seal member, such asthe lower portion, does not move. Instead, it can act as a pivot pointfor the rest of the seal. For example, the bottom portion of the can bemade thick, made from a less flexible material, includes supportstructures, or any combination thereof so that it is relativelynon-flexible. In which case, the rest of the seal would move about thispivot point. Of course, this type of pivot point can be provided atother locations of the seal member.

Seal member 300 includes a forehead support 330 provided on a foreheadarm 332. Forehead support supports a forehead pad (not shown) and can befixed to the support arm. However, the present invention alsocontemplates that forehead support 330 rotate relative to the foreheadarm, as indicated by arrow G, so that the forehead pad is properlyseated or aligned on the surface of the user. The present inventionfurther contemplates that the forehead support is moveable along theforehead arm, as indicated by arrow H, so that the position of theforehead pad can be adjusted to suit the needs of the user.

It can be appreciated that the present invention contemplates that theadjustment mechanism for controlling the position of the seal memberrelative to the face plate can have a wide varied of configurations.FIGS. 18-20 illustrate alternative exemplary embodiments for theadjustment mechanism that controls the position of a seal member 340relative to a faceplate 342. In FIG. 18, an adjustment mechanism 344 isshown that includes a pair of linkages 346 and 348. The end of eachlinkage is coupled to faceplate 354 such that it is moveable along aportion of the faceplate, as indicated by arrows I and J. The ends ofthe linkages can be moved in discrete positions along the teeth providedon the faceplate to control the position of the patient contactingportion of the seal member. In the embodiment shown in FIG. 18, thelinkages connect to a side of the faceplate proximate to the sealmember. In the embodiment shown in FIG. 19, linkages 346′ and 348′connect to a side of the faceplate opposite the seal member.

In FIG. 20, an adjustment mechanism 350 includes a pair of linkages 352and 354, only one of which (linkage 352) is adjustably coupled tofaceplate 342, as indicated by arrow K. Linkage 354 is rotatably coupledto the faceplate so that it can rotate as linkage 352 is moved. A thirdlinkage 356 couples the other linkage to an attachment ring 358 in sealmember 340. Linkages 352, 354, and 356 are rotatably coupled together atjoint 360.

A fifth embodiment of a patient interface 370 according to theprinciples of the present invention is illustrated in FIG. 21. In thisembodiment, a seal member 372 is coupled to a faceplate 374 such thatone end of the seal member is rotatably attached to the faceplate andanother end of the seal member is adjustably coupled to the faceplatevia an adjustment mechanism 376. To rotatably attach the seal member tothe faceplate a rotatable coupling 378 is provided at the lower portionof the patient interface.

Adjustment mechanism 376 includes a fixed length coupling member 380 anda moveable adjustment member 382 that is coupled to the faceplate andcoupling member 380. Coupling member 380 is coupled between adjustmentmember 382 and seal member 340, and, in particular, an attachment ring384, provided on the seal member. As a result, movement of adjustmentmember 382 along the faceplate, as indicated by arrow L, causes theupper portion of the seal member to move toward or away from thefaceplate, as indicated by arrow M. However, the lower portion the sealmember remains fixed to the lower portion of the faceplate so that theseal member rotates about and axis defined through rotatable coupling378.

FIG. 22 illustrates a patient interface 390 that is generally similar topatient interface 370 of FIG. 21, except that it includes a rotatablecoupling 392 between a seal member 394 and a faceplate 396 that islocated at a lower portion of the patient interface. An adjustmentmechanism 398 is provided to adjust the position of the patient contactportion of the seal member relative to the faceplate. In thisembodiment, adjustment mechanism 398 includes a fixed length couplingmember 400 and a moveable adjustment member 402 that is coupled to thefaceplate and coupling member 400. Adjustment member 402 is moveablealong a slot or track 404 defined in the faceplate, as indicated byarrow N. One end of coupling member 400 is rotatably attached toadjustment member 402 and another end is rotatably coupled to anattachment ring 406 of seal member 400. Movement of adjustment member402 along slot 404 in the faceplate causes the lower portion of the sealmember to move toward or away from the faceplate, as indicated by arrowO. However, the upper portion the seal member remains fixed to the upperportion of the faceplate so that the seal member rotates about and axisdefined through rotatable coupling 392.

Yet another embodiment for the adjustment mechanism that controls theposition of the seal member relative to the faceplate is discussed belowwith respect to the seventh embodiment of a patient interface 410 shownin FIGS. 23-24C. In this embodiment, patient interface 410 includes afaceplate 412, a seal member 414, and an adjustment mechanism 416 thatcontrols the position of the seal member relative to the faceplate. Sealmember 414 is defined by a cushion 415 and a rigid or semi-rigid supportmember 417 that is less flexible than the cushion. Adjustment mechanism416 includes a screw 418, which is also referred to as a “thumb screw”,that is attached to faceplate 412 and is rotated by the user. In anexemplary embodiment, screw 418 is mounted on a peg 419 that protrudesfrom the faceplate. See FIG. 25. Screw 418 engages teeth 420 provided onsupport member 417 of seal member 414 when the screw is rotated causingthe seal member to move relative to the faceplate, as indicated by arrowP.

FIGS. 24A-24C are side views illustrating the adjustment of the sealmember relative to the faceplate by adjustment mechanism 416. It can beappreciated from viewing these figures that rotation of the screw causesit to move along the teeth provided on the seal member, thereby changingthe angle between a plane 422, which is defined by the seal member, andthe faceplate. This embodiment allows the seal member to be placed in aninfinite number of positions relative to the faceplate over the range ofangles possible using adjustment mechanism 416. The present inventioncontemplates coupling the interior of the seal member with the patientcircuit via a flexible collar 442. 194 To maintain the seal member inalignment with the faceplate, patient interface 410 includes a guidemember 424 provided on faceplate 412, and a corresponding slot or track426 provided in seal member 414. Of course, the present inventioncontemplates that track 426 can be disposed on the faceplate and theguide member can be provided on the seal member. It should also be notedthat a track and guide member can be provided on each side of the mask,where only one side is shown in the illustrated embodiments. The guidemember and track are configured such that the guide member moves alongthe track, as indicated by arrow Q, during adjustment of the position ofthe seal member relative to the faceplate. It should be furtherunderstood that the location, size, and configuration the track andguide member can be varied so that the way in which the seal membermoves relative to the track can be controlled. For example, the presentinvention contemplates that the track can have an wavy configurationand/or can be wider in certain regions to allow for some degree offreedom of movement of the seal member relative to the faceplate.

FIGS. 25 and 26 illustrates an eighth embodiment of a patient interface430 according to the principles of the present invention. Patientinterface 430 is generally similar to patient interface 410 of FIGS.23-24C. However, patient interface 430 includes a technique for couplingseal member 414 to faceplate 412 that is different from the flexiblecollar and the guide member and track configuration of patient interface410 in the previous embodiment. In this embodiment, a collar 432 iscoupled in a groove 434 provided at an end portion 436 of couplingmember 46. A lip 438 maintains collar in an engaged relation with thecoupling member. Collar 432 flares outward from the coupling member andterminates in a peripheral edge 440.

A peripheral edge portion 442 of support member 417′ defines an opening444 that surrounds the coupling between collar 432/faceplate 412 andcoupling member 46. Thus, the peripheral edge portion of the supportmember is disposed between the collar and the faceplate. As seal member414 moves relative to the faceplate, support member 417′ moves relativeto collar 432. The shape of opening 444 defines the degree of movementthat is possible between the seal member and the faceplate.

In one embodiment, opening 444 has an elliptical shape with a widenedportion 446. This configuration allows the seal member to mover in avertical direction relative to the faceplate, as indicated by arrow R,and in a horizontal direction, as indicated by arrow S. The degree offreedom of movement is controlled by changing the dimensions of opening444. For example, opening 444 a is shown in FIG. 26 that is smaller thanopening 444. Thus, opening 444 a provides less freedom of movementbetween the seal member and the faceplate. If it is desired to limit themovement of the seal member relative to the faceplate to one dimension,such as in a vertical direction as indicated by arrow T, the opening canbe made in the form of a slot as shown by opening 444 c. It can beappreciated that the present invention contemplates a wide variety ofconfigurations for opening 444.

FIGS. 27 and 28 illustrate a ninth embodiment of a patient interface 450having yet another configuration for an adjustment mechanism 456 thatcouples a seal member 454 to a faceplate 452. It should be noted thatthe forehead support portion of the patient interface is omitted fromthese figures. Seal member 454 includes a cushion 458 and a supportmember 460 having a peripheral portion 462 to which the cushion ismounted. An opening 463 is defined in support member 460.

A collar 464, which includes a neck portion 466 and a flange 468 couplesthe seal member to the faceplate. As in the embodiment of FIG. 25, aperipheral portion of portion of support member 460 is sandwichedbetween a portion of flange 468 and a portion of the faceplate. Neckportion 466 passes through opening 463. As the seal member is moved byadjustment mechanism 456, support member 460 moves relative to collar464 and faceplate 452. Again, the shape of opening 463 controls how theseal member moves relative to the faceplate.

In this embodiment, adjustment mechanism 456 includes a manuallydeflectable arm 470 that extends from support potion 460. Contactingmembers 472 and a protrusion 474 are provided at the end of the arm.Adjustment mechanism 456 also includes a slot 476 provided on faceplate452. A plurality of notches or detents 478 are provided on the sides ofslot 476. When assembled, protrusion 474 extends above the exposedsurface of the faceplate and contacting members 472 engage on pair ofnotches 478. To change the position of the seal member relative to thefaceplate, the user depresses protrusion 474 to disengage the contactingmembers from the notches and slides the arm up or down the slot. Theuser then releases the arm, which is then biased again into engagementbetween the contacting member and the notches to maintain the sealmember in its new position.

A tenth embodiment of patient interface 480 is illustrated in FIG. 29,which is an exploded view the patient interface showing a faceplate 482and a seal member 484. The seal member includes a cushion (not shown)mounted onto a support member 487. At least a portion of an adjustmentmechanism, generally indicated at 486, is incorporated into the couplingbetween the seal member and the patient interface where the seal membercommunicates with coupling member 46. As in the previous embodiment, acollar 488, which includes a neck portion 490 and a flange 492 couplesthe seal member to the faceplate. Unlike the previous embodiment, collar488 is used to set the position of the seal member relative to the faceplate, and, thus, constitutes a portion of adjustment mechanism 486.

Neck portion 490 of collar 488 includes a pair of contacting members 494(only one of which is shown) each of which is provided on one side ofthe neck portion. Contact members 494 are sized and configured to engagenotches 495 provided on the sides of a slot 496. Support member 487 ofseal member 484 moves relative to faceplate 482 and collar 488 to changethe position of the patient contacting portion of the seal memberrelative to the faceplate. The engagement between notches 495 andcontact members 494 maintains the position of the seal member relativeto the faceplate. To facilitate movement of the seal member relative tothe faceplate, a protrusion 497 is provided extending from supportmember 487, and a slot 498 is provided in the faceplate. Protrusion 497extends through slot 498 so that the user can grasp or push theprotrusion to change the position of the seal member relative to thefaceplate.

FIG. 30 illustrates an eleventh embodiment of a patient interface 500according to the principles of the present invention. Patient interface500 includes a faceplate 502, a seal member 504, and an adjustmentmechanism, generally indicated at 506. In this embodiment, adjustmentmechanism 506 includes a pair of manually actuated knobs or wheels 508disposed on either side of the faceplate and rotatably coupled to thefaceplate. Knobs 508 engage seal member which is flexibly coupled to thefaceplate and coupling member 46 such that rotating the knobs moves theseal member relative to the faceplate, as indicated by arrows U.Friction or a locking mechanism (not shown) can be used to preventmovement of the knobs.

The present invention also contemplates that knobs 508 only engage theseal member when it is desired to change the position of the seal memberrelative to the faceplate. At all other times, the knobs are disengagedfrom the faceplate. In an exemplary embodiment of the present invention,this is accomplished by providing engagement tracks 510 on seal member504. Knobs 504 are actuated to engage tracks 510 by moving them in alateral direction, for example by squeezing the knobs to move themtoward the center of the faceplate. A biasing mechanism, such as aspring, causes the knobs to disengage from the tracks once the squeezingfor is released. In the illustrated embodiment, multiple tracks 510 areprovided on the seal member to ensure that the knobs engage the tracksto move the seal member.

FIG. 31 illustrates a twelfth embodiment of a patient interface 520according to the principles of the present invention. Patient interface520 includes a faceplate 522, a seal member 524, and an adjustmentmechanism, generally indicated at 526. It should be noted that sealmember 524, as shown, only includes a support member 528. The patientcontacting cushion that attaches to support member 528 is not shown. Itshould be noted that the cushion can be attached to support member 528such that the cushion and support member define a unitary structure. Thepresent invention also contemplates using the support member as collar432 cushion be

In this embodiment, adjustment mechanism 526 includes a lock nut 530that attaches to a neck portion 532 of support member 528. Threads onthe lock nut and the neck portion attach these components together.However, other techniques are contemplated by the present invention.Neck portion 532 passes through an orifice 534 defined in faceplate 502and attaches to the lock nut. It is to be understood that couplingmember 46 is attached to the faceplate or the lock nut. It should alsobe noted that the components of patient interface 520 are not drawn toscale.

FIG. 32 is an exploded view of a thirteenth embodiment of a patientinterface 540 according to the principles of the present invention.Patient interface 540 includes a faceplate 542 and a seal member 544. Itshould be noted that seal member 544, as shown, only includes a supportmember 546. The patient contacting cushion that attaches to supportmember 546 is not shown. In this embodiment, the cushion attaches to anend portion 548 of support member 546.

A collar 550 is seated in support member 546 and secures the supportmember against faceplate 542 in a manner similar to that of collar 432in FIG. 25. A biasing mechanism in the form a spring 552 urges a flange554 of collar 550 toward the inner surface of the faceplate. This can beaccomplished, for example, by using the spring to “push” the faceplatetoward the flange of the collar or by having the spring “pull” thecollar toward the faceplate. Collar 554 remains fixed in positionrelative to faceplate 542 and coupling member 46. However, seal supportmember 546 is moveable relative to the these components. A neck portion556 of collar 550 is inserted through an orifice 558 of support member546 and an orifice 560 of faceplate 542 and is operatively coupledcoupling member 46.

A plurality of teeth 562 are provided on a surface of the collar, andcorresponding teeth engaging components 564 are provided on a surface ofseal support member 546 that confronts the teeth carrying surface of thecollar. Teeth 562 and teeth engaging components 564 cooperate to providediscrete positions for the seal member relative to the faceplate. Tochange the position of the seal member relative to the faceplate, theuser pulls the seal member slightly away from the faceplate against thebias force of spring 552 far enough to disengage the teeth 562 fromteeth engaging components 564. The user then moves the seal member tothe new position and releases the seal member, allowing the teeth toreengage the teeth engaging components at the new position, therebypreventing any unwanted movement between the seal member and thefaceplate.

It is to be understood that the present invention contemplates that theteeth and the teeth engaging components can have a variety ofconfigurations and can be provided at a variety of locations on thecollar and the seal support member. For example, a tongue and grooveconfiguration can be used. In addition, the location of the teeth andthe teeth engaging components can be reversed so that the teeth areprovided on the seal support member.

In this embodiment, faceplate 542 has a pair of lateral arms 566 thatextend from each side of a central portion of the faceplate. The lateralarms are configured and arranged so to be positioned over the user'scheeks when the patient interface is being worn by the user. Pads 568are connected to the lateral arms to contact the surface of the user.

FIG. 33 is a side view, partially in section, of a fourteenth embodimentof a patient interface 570 according to the principles of the presentinvention. Patient interface 570 includes a faceplate 572 and a sealmember 574. Seal member 574 includes a cushion 576 and a seal supportmember 578. The adjustment mechanism by which the seal member isadjustably relative to the faceplate is generally similar to that usedin patient interface 540 of FIG. 32. Namely, seal support member 578 issecured between a collar 580 and the faceplate. A spring 552, which issecured around a neck portion 582 of collar 580, biases the collar andfaceplate against one another to hold the seal support member in place.The main functional difference resides in the location of the teeth thatare used maintain the seal member in a fixed position relative to thefaceplate.

In patient interface 570 of FIG. 33, a first group of teeth 584 areprovided on surface of seal support member 578 and a second group ofteeth 586 are provided on an interior surface of faceplate 572. Teeth584 and 586 selectively engage one another to hold the seal member inposition relative to the faceplate. Unlike the previous embodiment, thesurface of the collar does not include any mechanism, such as teeth, forsecuring the seal member in place. It is to be understood that teeth 584and 584 can have a variety of configures, and need not be “teeth”.Rather, other structures such as a tongue and groove, or a frictionsurface can also be used to keep the components of the patient interfacefrom moving until manually actuated by the user.

FIG. 34 is a side sectional view of a portion of a further embodiment ofpatient interface 590 according to a fifteenth embodiment of the presentinvention. This embodiment is provided to illustrate alternativeconfigurations for coupling a seal member 594 to a faceplate 592 and forcommunicating a flow of gas to the interior of the seal member. Itshould be noted that this figure does not show an structure forcontrolling the position of the seal member relative to the faceplate,but any of the techniques described herein can be used for that purpose.This figure also does not show the forehead support portion of thepatient interface device. It is to be understood that any configurationfor the forehead support, or the forehead support can be eliminatedentirely.

In this embodiment, gas flow from the patient circuit is communicated toa forehead arm 596, which has a hollow interior, so that the gas flowpasses through the forehead arm, as indicated by arrows V. The hollowinterior of forehead arm 596 communicates with the interior of sealmember 594 via a flexible collar 598. Seal member 594 includes a cushion600 and a seal support member 602. One end of flexible collar 598 iscoupled to faceplate 592 and another end is coupled to support member602.

Another feature of patient interface 590 is the ability to control theposition of the seal member relative to the faceplate in a verticaldirection. That is, the seal member can be moved in a verticaldirection, as indicate by arrow W and set in one of a plurality ofdiscrete locations relative to the faceplate. This is accomplished byproviding a slot 604 having a plurality of notches in a support member606, which is attached to and extends from seal support member 602. Acoupling member 608 is configured to be selectively disposed on one ofthe notches in slot 604. Coupling member 608 is rotatable within eachnotch so that the angle between a planed defined by the faceplate and aplane defined by the seal member can be changed, as indicated by arrowX.

A sixteenth embodiment of a patient interface 610 according to theprinciples of the present invention is illustrated in FIGS. 35 and 36.Patient interface 610 includes a faceplate 612 and a seal member 614. Inthis embodiment, faceplate 612 is relatively small and is little morethan a frame that support the seal member. Seal member 614 includes acushion 616 and a seal support member 618. Faceplate 612 includes a pairof arm 620 that diverge from a forehead arm 622 and travel alongopposite sides of seal support member 618. The ends of arms 620 arecoupled to seal member 614 via an adjustment mechanism 624, which allowsthe user to set the position of the seal member relative to thefaceplate. That is, adjustment mechanism 624 allows the seal member torotate relative to the faceplate, as indicated by arrow Y, and allowsthe user lock the seal member at one of a plurality of discretepositions relative to the faceplate. The axis of rotation is definedthrough adjustment mechanisms 624.

In the illustrated exemplary embodiment, adjustment mechanism 624 is apush-button, ratchet mechanism that includes a spring-loaded button 626having a plurality of teeth 628. When depressed, as indicated by arrowZ, teeth 628 are disengaged from a corresponding locking member 630 sothat the seal member can be rotated relative to the faceplate. Whenreleased, the teeth engage the locking members preventing movement ofthe seal member relative to the faceplate.

FIGS. 37 and 38 illustrate a seventeenth embodiment of a patientinterface 640 according to the principles of the present invention.Patient interface 640, which is generally similar to patient interface610 of the previous embodiment except for the configuration for theadjustment mechanism, includes a faceplate 642 and a seal member 644.Faceplate 642 includes a pair of arms 646 and a forehead arm 648. Sealmember 644 includes a cushion 650, which contacts the user, and a sealsupport portion 652, which supports the cushion and couples it to thefaceplate.

In this embodiment, an adjustment mechanism 654 is associated with eacharm 646 to allow selective angular adjustment of the seal memberrelative to the faceplate. Adjustment mechanism 654 includes a slot 656provided in seal support portion 652 and a corresponding coupling member658, which in this embodiment is a pin, that is moveable in the slot.Slot 654 also includes a plurality of notches 660 in which the couplingmember sits to provide a plurality of discrete positions for the sealmember relative to the faceplate. Adjustment mechanism 654 also includesa slot 662 provided at a lower portion of seal support member 658 and acorresponding coupling member 664, which in this embodiment is also apin, that is moveable in slot 662. Slot 662 is shaped to allow the sealmember to be moved relative to the seal so that coupling member 658 isdisengaged from slot 654 and moved back into engagement at a desiredlocation, as indicated by arrow AA. This is accomplished by structuringslot 662 so that it has an upper portion 666 and a lower portion 668.When disengaged, i.e., when coupling member 664, is disposed in an upperportion 666 of slot 662, the seal member is rotatable relative tofaceplate 642, as indicated by arrow BB, and pin 658 slides in slot 654.Then the desired position is reached, coupling member 664 is moved intolower portion 668 of slot 662 and coupling member 658 is seated into oneof the notches in slot 656.

It is to be understood that the present invention contemplates usingother techniques for the adjustment mechanism in the embodiments ofFIGS. 35-38. For example, a friction lock using a lock nut provided asthe end of each arm can be used to lock the seal member in place withrespect to the faceplate. In addition, while the threads described inthe adjustment mechanisms are illustrated as being conventional threads,it is to be understood that the present invention contemplates other“non-traditional” threads, such as reverse threads and multiple splinethreads.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

1. A patient interface comprising: a faceplate including a plurality ofheadgear attachment elements, the faceplate having a recess extendingtherethrough; a seal member operatively coupled to the faceplate; and anadjustment mechanism coupling the seal member to the faceplate such thatthe seal member is adjustable relative to the faceplate from a firstposition to a second position and maintains the seal member in thesecond position during use of the patient interface, wherein theadjustment mechanism includes: (i) a first member received within therecess and rotatable within the recess, and (ii) a threaded membercoupled to the first member and the seal member, wherein rotation of thefirst member within the recess causes the threaded member to moverelative to the first member and the seal member to move relative to thefaceplate, wherein the first member comprises a knob portion havingfirst threads provided on an interior surface of the knob portion and abarrel portion having second threads provided on an exterior surface ofthe barrel portion, wherein the knob portion is coupled to the barrelportion through engagement of the first threads with the second threads,the threaded member being coupled to the barrel portion, whereinrotation of the knob portion causes rotation of the barrel portionwithin the recess at a fixed position, and wherein rotation of thebarrel portion causes the threaded member to move relative to the firstmember.
 2. The patient interface of claim 1, further comprising a sealsupport member operatively coupled to the seal member, and wherein theadjustment mechanism is coupled between the seal support member and thefaceplate so as to move the seal support member relative to thefaceplate.
 3. The patient interface of claim 2, wherein the seal supportmember is an generally rigid annular ring disposed around the sealmember.
 4. The patient interface of claim 1, wherein the seal membercomprises a cushion having a first end portion and a second end portiongenerally opposite the first end portion, wherein the first end portionincludes a flexible sealing surface adapted to surround a user's nares,and wherein an opening is defined in the first end portion of thecushion for receiving a portion of such a user.
 5. The patient interfaceof claim 1, wherein the faceplate comprises: a seal support portion; aforehead portion; and an arm connecting the seal support portion withthe forehead portion.
 6. The patient interface of claim 1, furthercomprising a conduit coupling member coupled to faceplate, the sealmember, or both.
 7. The patient interface of claim 6, further comprisingan exhaust assembly disposed on the faceplate, the conduit couplingmember, or both.
 8. The patient interface of claim 1, wherein the sealmember comprises: a patient contacting portion adapted to contact asurface of patient during use of the patient interface; a faceplatecontacting portion operatively coupled to the faceplate; and a sidewallextending between the patient contacting portion and the faceplatecontacting portion.
 9. The patient interface of claim 8, wherein thesidewall portion includes at least one bellows defined therein.
 10. Apatient interface comprising: sealing means for providing a sealedcontact with a user, wherein the sealing means includes a flexible firstend portion including a patient contacting surface and a second endportion; supporting means for supporting the sealing means on a user,the supporting means having a recess extending therethrough; headgearattaching means for attaching a headgear to the supporting means; andadjusting means, operatively coupled to the sealing means and thesupporting means, for adjusting the sealing means relative to thesupporting means manually from a first position to a second position andmaintaining the sealing means in the second position responsive to beingadjusted, wherein the adjusting means includes: (i) a first memberreceived within the recess and rotatable within the recess, and (ii) athreaded member coupled to the first member and the sealing means,wherein rotation of the first member within the recess causes thethreaded member to move relative to the first member and the sealingmeans to move relative to the supporting means, wherein the first membercomprises a knob portion having first threads provided on an interiorsurface of the knob portion and a barrel portion having second threadsprovided on an exterior surface of the barrel portion, wherein the knobportion is coupled to the barrel portion through engagement of the firstthreads with the second threads, the threaded member being coupled tothe barrel portion, wherein rotation of the knob portion causes rotationof the barrel portion within the recess at a fixed position, and whereinrotation of the barrel portion causes the threaded member to moverelative to the first member.
 11. The patient interface of claim 10,wherein the sealing means comprise: a cushion having a first end portionand a second end portion generally opposite the first end portion, andwherein the first end portion includes a sealing surface for contactinga surface of a user; and a seal support member coupled to the second endportion of the cushion.
 12. The patient interface of claim 1, wherein aninterior of the barrel portion is not threaded and wherein a distal endof the barrel portion includes a tab extending inwardly toward theinterior of the barrel portion that engages third threads provided onthe threaded member.
 13. The patient interface of claim 10, wherein aninterior of the barrel portion is not threaded and wherein a distal endof the barrel portion includes a tab extending inwardly toward theinterior of the barrel portion that engages third threads provided onthe threaded member.
 14. The patient interface of claim 12, wherein aninterior of the knob portion includes a longitudinally extendingalignment member, wherein the threaded member includes a longitudinallyextending channel, and wherein the alignment member is received withinthe channel to keep the threaded member aligned as the threaded membermoves relative to the first member.
 15. The patient interface of claim13, wherein an interior of the knob portion includes a longitudinallyextending alignment member, wherein the threaded member includes alongitudinally extending channel, and wherein the alignment member isreceived within the channel to keep the threaded member aligned as thethreaded member moves relative to the first member.
 16. The patientinterface of claim 14, wherein one of a distal end of the threadedmember and a top, central portion of the seal member includes a socketand the other of the distal end of the threaded member and the top,central portion of the seal member includes a ball moveably receivedwithin the socket.
 17. The patient interface of claim 15, wherein one ofa distal end of the threaded member and a top, central portion of theseal means includes a socket and the other of the distal end of thethreaded member and the top, central portion of the seal means includesa ball moveably received within the socket.